R version 4.6.0 alpha (2026-03-30 r89742 ucrt) Copyright (C) 2026 The R Foundation for Statistical Computing Platform: x86_64-w64-mingw32/x64 R is free software and comes with ABSOLUTELY NO WARRANTY. You are welcome to redistribute it under certain conditions. Type 'license()' or 'licence()' for distribution details. R is a collaborative project with many contributors. Type 'contributors()' for more information and 'citation()' on how to cite R or R packages in publications. Type 'demo()' for some demos, 'help()' for on-line help, or 'help.start()' for an HTML browser interface to help. Type 'q()' to quit R. > # This file is part of the standard setup for testthat. > # It is recommended that you do not modify it. > # > # Where should you do additional test configuration? > # Learn more about the roles of various files in: > # * https://r-pkgs.org/testing-design.html#sec-tests-files-overview > # * https://testthat.r-lib.org/articles/special-files.html > > library(testthat) > library(rDataRecon) > > test_check("rDataRecon") --- SCENARIO 1: ADaM ADSL — Subject Level: Programmer vs Biostatistics Review --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : adsl_v1 6 obs x 17 vars COMPARE : adsl_v2 6 obs x 17 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:08 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (12): [suppressed] Variables WITH differences (4): SAFFL, PPROTFL, DTHFL, BMIBL Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = STUDY001-003 SAFFL Y N USUBJID = STUDY001-004 PPROTFL Y N USUBJID = STUDY001-005 DTHFL N Y USUBJID = STUDY001-002 BMIBL 24.8 24.9 0.1 SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 6 Obs in COMPARE 6 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 17 Variables in COMPARE 17 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 16 Variables with all values equal 12 Variables with any differences 4 Total value differences 4 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : adsl_v1 6 obs x 17 vars COMPARE : adsl_v2 6 obs x 17 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:08 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 6 Obs in COMPARE 6 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 17 Variables in COMPARE 17 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 16 Variables with all values equal 12 Variables with any differences 4 Total value differences 4 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== [ADSL QC] 4 flag(s) changed — SAFFL/PPROTFL/DTHFL impact population counts! --- SCENARIO 2: ADaM ADAE — AE Analysis Dataset: Pre vs Post Medical Review --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : adae_v1 7 obs x 12 vars COMPARE : adae_v2 7 obs x 12 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:08 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (5): [suppressed] Variables WITH differences (5): AESEV, AESEVN, AREL, AESDTH, ANL01FL Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = STUDY001-002 | AES AESEV MILD MODERATE USUBJID = STUDY001-002 | AES AESEVN 1 2 1 USUBJID = STUDY001-004 | AES AREL Y N USUBJID = STUDY001-003 | AES AESDTH N Y USUBJID = STUDY001-005 | AES ANL01FL Y N SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 7 Obs in COMPARE 7 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 12 Variables in COMPARE 12 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 10 Variables with all values equal 5 Variables with any differences 5 Total value differences 5 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : adae_v1 7 obs x 12 vars COMPARE : adae_v2 7 obs x 12 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:08 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 7 Obs in COMPARE 7 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 12 Variables in COMPARE 12 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 10 Variables with all values equal 5 Variables with any differences 5 Total value differences 5 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== *** SAE DEATH flag changed — regulatory notification may be required! *** --- SCENARIO 3: ADaM ADLB — Lab Analysis: Derivation QC (CHG, PCHG, Flags) --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : adlb_derived 8 obs x 13 vars COMPARE : adlb_qc 8 obs x 13 vars Criterion : 0.0001 (absolute) Run time : 2026-03-31 10:17:08 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (8): [suppressed] Variables WITH differences (2): PCHG, ANRIND Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = STUDY001-001 | PAR PCHG -5.19 -5.185 0.005 USUBJID = STUDY001-002 | PAR PCHG 9.52 9.524 0.004 USUBJID = STUDY001-002 | PAR ANRIND LOW NORMAL SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 13 Variables in COMPARE 13 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 10 Variables with all values equal 8 Variables with any differences 2 Total value differences 3 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== --- SCENARIO 4: ADaM ADTTE — Time-to-Event: PFS Endpoint QC --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : adtte_v1 8 obs x 10 vars COMPARE : adtte_v2 8 obs x 10 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:08 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (5): [suppressed] Variables WITH differences (3): AVAL, CNSR, EVNTDESC Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = STUDY001-001 | PAR AVAL 185 190 5 USUBJID = STUDY001-002 | PAR AVAL 92 95 3 USUBJID = STUDY001-002 | PAR CNSR 1 0 1 USUBJID = STUDY001-002 | PAR EVNTDESC CENSORED-LAST CONT PD SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 10 Variables in COMPARE 10 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 8 Variables with all values equal 5 Variables with any differences 3 Total value differences 4 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : adtte_v1 8 obs x 10 vars COMPARE : adtte_v2 8 obs x 10 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:08 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 10 Variables in COMPARE 10 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 8 Variables with all values equal 5 Variables with any differences 3 Total value differences 4 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== [ADTTE QC] Primary endpoint (PFS) changes: 4 — impact KM analysis! --- SCENARIO 5: ADaM BDS — QoL/PRO: Scoring Algorithm v1 vs v2 (SAP update) --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : adcfb_v1 9 obs x 9 vars COMPARE : adcfb_v2 9 obs x 9 vars Criterion : 0.01 (absolute) Run time : 2026-03-31 10:17:08 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (3): [suppressed] Variables WITH differences (3): AVAL, PCHG, ABLFL Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = STUDY001-002 | PAR AVAL 0.78 0.792 0.012 USUBJID = STUDY001-002 | PAR AVAL 0.72 0.731 0.011 USUBJID = STUDY001-002 | PAR AVAL 0.81 0.823 0.013 USUBJID = STUDY001-002 | PAR PCHG 8.33 8.48 0.15 USUBJID = STUDY001-002 | PAR PCHG 12.5 12.76 0.26 USUBJID = STUDY001-003 | PAR ABLFL Y NA SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 9 Obs in COMPARE 9 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 9 Variables in COMPARE 9 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 6 Variables with all values equal 3 Variables with any differences 3 Total value differences 6 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== --- Side-by-side numeric summary (AVAL, CHG, PCHG) --- variable base_mean compare_mean base_sd compare_sd base_min compare_min 1 AVAL 24.256667 24.260667 34.406231 34.403160 0.72 0.731 2 CHG 1.350000 1.350333 3.768441 3.768315 -2.00 -2.000 3 PCHG -6.233333 -6.187778 26.756792 26.789898 -66.67 -66.670 base_max compare_max mean_diff 1 75.00 75.00 -0.0040000000 2 10.00 10.00 -0.0003333333 3 15.38 15.38 -0.0455555556 ======================================================================== ADAM SCENARIOS — SUMMARY ======================================================================== No. Domain Use Case Result ---- ------------ -------------------------------- ---------------------- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 6 obs x 17 vars COMPARE : s[[5]] 6 obs x 17 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:08 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 6 Obs in COMPARE 6 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 17 Variables in COMPARE 17 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 16 Variables with all values equal 12 Variables with any differences 4 Total value differences 4 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 01 ADaM ADSL Programmer vs Biostatistics Review HAS DIFFERENCES (4 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 7 obs x 12 vars COMPARE : s[[5]] 7 obs x 12 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:08 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 7 Obs in COMPARE 7 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 12 Variables in COMPARE 12 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 10 Variables with all values equal 5 Variables with any differences 5 Total value differences 5 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 02 ADaM ADAE Pre vs Post Medical Review HAS DIFFERENCES (5 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 8 obs x 13 vars COMPARE : s[[5]] 8 obs x 13 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:08 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 13 Variables in COMPARE 13 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 10 Variables with all values equal 8 Variables with any differences 2 Total value differences 3 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 03 ADaM ADLB Derivation QC (CHG, PCHG, Flags) HAS DIFFERENCES (3 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 8 obs x 10 vars COMPARE : s[[5]] 8 obs x 10 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:08 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 10 Variables in COMPARE 10 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 8 Variables with all values equal 5 Variables with any differences 3 Total value differences 4 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 04 ADaM ADTTE Time-to-Event: PFS Endpoint QC HAS DIFFERENCES (4 diff) ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : base_df 5 obs x 3 vars COMPARE : base_df 5 obs x 3 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:08 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (2): age, name Variables WITH differences (0): none SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 5 Obs in COMPARE 5 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 3 Variables in COMPARE 3 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 2 Variables with all values equal 2 Variables with any differences 0 Total value differences 0 ======================================================================== VERDICT : DATASETS ARE IDENTICAL ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : base_df 5 obs x 3 vars COMPARE : base_df 5 obs x 3 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:08 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (2): age, name Variables WITH differences (0): none SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 5 Obs in COMPARE 5 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 3 Variables in COMPARE 3 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 2 Variables with all values equal 2 Variables with any differences 0 Total value differences 0 ======================================================================== VERDICT : DATASETS ARE IDENTICAL ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : base_df 5 obs x 3 vars COMPARE : comp 5 obs x 3 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:08 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (1): name Variables WITH differences (1): age Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ id = 2 age 30 99 69 SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 5 Obs in COMPARE 5 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 3 Variables in COMPARE 3 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 2 Variables with all values equal 1 Variables with any differences 1 Total value differences 1 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : base_df 5 obs x 3 vars COMPARE : comp 5 obs x 3 vars Criterion : 2 (absolute) Run time : 2026-03-31 10:17:08 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (2): age, name Variables WITH differences (0): none SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 5 Obs in COMPARE 5 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 3 Variables in COMPARE 3 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 2 Variables with all values equal 2 Variables with any differences 0 Total value differences 0 ======================================================================== VERDICT : DATASETS ARE IDENTICAL ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : base_df 5 obs x 3 vars COMPARE : comp 5 obs x 3 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:08 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (1): age Variables WITH differences (1): name Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ id = 1 name Alice alice SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 5 Obs in COMPARE 5 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 3 Variables in COMPARE 3 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 2 Variables with all values equal 1 Variables with any differences 1 Total value differences 1 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : b 2 obs x 2 vars COMPARE : c1 2 obs x 2 vars Criterion : 0.01 (relative) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (1): val Variables WITH differences (0): none SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 2 Obs in COMPARE 2 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 2 Variables in COMPARE 2 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 1 Variables with all values equal 1 Variables with any differences 0 Total value differences 0 ======================================================================== VERDICT : DATASETS ARE IDENTICAL ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : b 2 obs x 2 vars COMPARE : c2 2 obs x 2 vars Criterion : 0.01 (relative) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (0): none Variables WITH differences (1): val Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ id = 2 val 2000 2200 0.1 (rel) SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 2 Obs in COMPARE 2 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 2 Variables in COMPARE 2 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 1 Variables with all values equal 0 Variables with any differences 1 Total value differences 1 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : b 3 obs x 2 vars COMPARE : structure(list(id = 1:3, revenue = c(100, 250, 300)), class = "data.frame", row.names = c(NA, 3 obs x 2 vars COMPARE : -3L)) 3 obs x 2 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (0): none Variables WITH differences (1): revenue Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ id = 2 revenue 200 250 50 SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 3 Obs in COMPARE 3 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 2 Variables in COMPARE 2 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 1 Variables with all values equal 0 Variables with any differences 1 Total value differences 1 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : base_df 5 obs x 3 vars COMPARE : comp 5 obs x 2 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 1) : age In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (1): name Variables WITH differences (0): none SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 5 Obs in COMPARE 5 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 3 Variables in COMPARE 2 Variables in BASE only 1 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 1 Variables with all values equal 1 Variables with any differences 0 Total value differences 0 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : base_df 5 obs x 3 vars COMPARE : comp 5 obs x 4 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 1) : extra SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (2): age, name Variables WITH differences (0): none SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 5 Obs in COMPARE 5 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 3 Variables in COMPARE 4 Variables in BASE only 0 Variables in COMPARE only 1 Variables with type mismatches 0 Variables compared 2 Variables with all values equal 2 Variables with any differences 0 Total value differences 0 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : base_df 5 obs x 3 vars COMPARE : comp 5 obs x 3 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ Variable BASE class COMPARE class ---------------------- ------------------ ------------------ age integer character SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (1): name Variables WITH differences (0): none SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 5 Obs in COMPARE 5 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 3 Variables in COMPARE 3 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 1 Variables compared 1 Variables with all values equal 1 Variables with any differences 0 Total value differences 0 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : b 3 obs x 3 vars COMPARE : c 3 obs x 3 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (0): none Variables WITH differences (1): score Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ site = A | period = 2 score 20 99 79 SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 3 Obs in COMPARE 3 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 3 Variables in COMPARE 3 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 1 Variables with all values equal 0 Variables with any differences 1 Total value differences 1 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : b 3 obs x 1 vars COMPARE : c 3 obs x 1 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (0): none Variables WITH differences (1): x Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ 2 x 2 99 97 SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 3 Obs in COMPARE 3 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 2 Variables in COMPARE 2 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 1 Variables with all values equal 0 Variables with any differences 1 Total value differences 1 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : b 3 obs x 2 vars COMPARE : c 3 obs x 2 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (0): none Variables WITH differences (1): score Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ id = 2 score 20 99 79 SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 3 Obs in COMPARE 3 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 2 Variables in COMPARE 2 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 1 Variables with all values equal 0 Variables with any differences 1 Total value differences 1 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : base_df 5 obs x 3 vars COMPARE : comp 3 obs x 3 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (0): none Variables WITH differences (2): age, name Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ id = 4 age 40 NA NA vs value id = 5 age 45 NA NA vs value id = 4 name Dave NA id = 5 name Eve NA SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 5 Obs in COMPARE 3 Obs in BASE only 2 Obs in COMPARE only 0 Variables in BASE 3 Variables in COMPARE 3 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 2 Variables with all values equal 0 Variables with any differences 2 Total value differences 4 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : base_df 5 obs x 3 vars COMPARE : comp 5 obs x 3 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (1): name Variables WITH differences (1): age Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ id = 1 age 25 99 74 SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 5 Obs in COMPARE 5 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 3 Variables in COMPARE 3 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 2 Variables with all values equal 1 Variables with any differences 1 Total value differences 1 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : base_df 5 obs x 3 vars COMPARE : base_df 5 obs x 3 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (2): age, name Variables WITH differences (0): none SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 5 Obs in COMPARE 5 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 3 Variables in COMPARE 3 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 2 Variables with all values equal 2 Variables with any differences 0 Total value differences 0 ======================================================================== VERDICT : DATASETS ARE IDENTICAL ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : base_df 5 obs x 3 vars COMPARE : base_df 5 obs x 3 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (2): age, name Variables WITH differences (0): none SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 5 Obs in COMPARE 5 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 3 Variables in COMPARE 3 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 2 Variables with all values equal 2 Variables with any differences 0 Total value differences 0 ======================================================================== VERDICT : DATASETS ARE IDENTICAL ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : base_df 5 obs x 3 vars COMPARE : base_df 5 obs x 3 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : base_df 5 obs x 3 vars COMPARE : comp 5 obs x 3 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (1): name Variables WITH differences (1): age Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ id = 1 age 25 99 74 SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 5 Obs in COMPARE 5 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 3 Variables in COMPARE 3 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 2 Variables with all values equal 1 Variables with any differences 1 Total value differences 1 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== Report written to: D:\temp\2026_03_31_10_15_16_22831\Rtmp0G23n4\file8a64767b781f.txt ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : base_df 5 obs x 3 vars COMPARE : comp 5 obs x 3 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (0): none Variables WITH differences (1): age Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ id = 1 age 25 99 74 SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 5 Obs in COMPARE 5 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 3 Variables in COMPARE 3 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 1 Variables with all values equal 0 Variables with any differences 1 Total value differences 1 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon: SDTM & ADaM Dataset Comparison Scenarios CDISC-aligned | Submission-grade | FDA/EMA best practices ======================================================================== --- SCENARIO 1: SDTM DM — Demographics: Data Cut 1 vs Data Cut 2 --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : dm_cut1 6 obs x 12 vars COMPARE : dm_cut2 6 obs x 12 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (8): [suppressed] Variables WITH differences (3): RFENDTC, ACTARMCD, AGE Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = STUDY001-003 RFENDTC NA 2023-07-22 USUBJID = STUDY001-004 ACTARMCD TRT B TRT A USUBJID = STUDY001-006 AGE 39 40 1 SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 6 Obs in COMPARE 6 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 12 Variables in COMPARE 12 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 11 Variables with all values equal 8 Variables with any differences 3 Total value differences 3 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== Report written to: sdtm_dm_comparison.txt ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : dm_cut1 6 obs x 12 vars COMPARE : dm_cut2 6 obs x 12 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 6 Obs in COMPARE 6 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 12 Variables in COMPARE 12 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 11 Variables with all values equal 8 Variables with any differences 3 Total value differences 3 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== [QC RESULT] DM changes: 3 value difference(s) across 3 variable(s) --- SCENARIO 2: SDTM AE — Adverse Events: Sponsor vs CRO Reconciliation --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : ae_sponsor 7 obs x 11 vars COMPARE : ae_cro 7 obs x 11 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (6): [suppressed] Variables WITH differences (3): AESEV, AEREL, AEOUT Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = STUDY001-002 | AES AESEV MILD MODERATE USUBJID = STUDY001-004 | AES AEREL POSSIBLY RELATED RELATED USUBJID = STUDY001-003 | AES AEOUT NOT RECOVERED FATAL SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 7 Obs in COMPARE 7 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 11 Variables in COMPARE 11 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 9 Variables with all values equal 6 Variables with any differences 3 Total value differences 3 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== Report written to: sdtm_ae_comparison.txt ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : ae_sponsor 7 obs x 11 vars COMPARE : ae_cro 7 obs x 11 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 7 Obs in COMPARE 7 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 11 Variables in COMPARE 11 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 9 Variables with all values equal 6 Variables with any differences 3 Total value differences 3 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== *** CRITICAL: FATAL outcome discrepancy detected — expedited review required! *** obs_id variable base_value compare_value diff 3 USUBJID = STUDY001-003 | AESEQ = 1 AEOUT NOT RECOVERED FATAL --- SCENARIO 3: SDTM LB — Lab Data: Central Lab Extract vs SDTM Mapped --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : lb_raw 8 obs x 13 vars COMPARE : lb_sdtm 8 obs x 13 vars Criterion : 0.001 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (8): [suppressed] Variables WITH differences (3): LBORRES, LBSTRESN, LBNRIND Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = STUDY001-004 | LBS LBORRES 9.1 9.10 USUBJID = STUDY001-003 | LBS LBSTRESN 5.9 6 0.1 USUBJID = STUDY001-004 | LBS LBNRIND LOW NORMAL SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 13 Variables in COMPARE 13 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 11 Variables with all values equal 8 Variables with any differences 3 Total value differences 3 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== --- SCENARIO 4: SDTM CM — Conmed: eCRF vs WHODrug Coded Dataset --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : cm_ecrf 6 obs x 11 vars COMPARE : cm_coded 6 obs x 11 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (0): [suppressed] Variables WITH differences (3): CMDECOD, CMCLAS, CMCLASCD Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = STUDY001-001 | CMS CMDECOD ASPIRIN ACETYLSALICYLIC AC USUBJID = STUDY001-005 | CMS CMCLAS ANTACIDS PROTON PUMP INHIBI USUBJID = STUDY001-005 | CMS CMCLASCD A02BC A02BC01 SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 6 Obs in COMPARE 6 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 11 Variables in COMPARE 11 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 3 Variables with all values equal 0 Variables with any differences 3 Total value differences 3 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== --- SCENARIO 5: SDTM VS — Vital Signs: Baseline vs Week 24 Derivation QC --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : vs_v1 8 obs x 11 vars COMPARE : vs_v1_qc 8 obs x 11 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (7): [suppressed] Variables WITH differences (2): VSBLFL, EPOCH Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = STUDY001-002 | VST VSBLFL Y NA USUBJID = STUDY001-002 | VST VSBLFL Y NA USUBJID = STUDY001-001 | VST EPOCH TREATMENT SCREENING USUBJID = STUDY001-001 | VST EPOCH TREATMENT SCREENING USUBJID = STUDY001-001 | VST EPOCH TREATMENT SCREENING USUBJID = STUDY001-001 | VST EPOCH TREATMENT SCREENING USUBJID = STUDY001-002 | VST EPOCH TREATMENT SCREENING USUBJID = STUDY001-002 | VST EPOCH TREATMENT SCREENING USUBJID = STUDY001-002 | VST EPOCH TREATMENT SCREENING USUBJID = STUDY001-002 | VST EPOCH TREATMENT SCREENING SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 11 Variables in COMPARE 11 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 9 Variables with all values equal 7 Variables with any differences 2 Total value differences 10 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== --- SCENARIO 6: SDTM EX — Exposure: Planned vs Actual Dose --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : ex_planned 6 obs x 12 vars COMPARE : ex_actual 6 obs x 12 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (6): [suppressed] Variables WITH differences (4): EXDOSE, EXROUTE, EXENDTC, EPOCH Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = DR001-002 | EXSEQ EXDOSE 10 5 5 USUBJID = DR001-004 | EXSEQ EXROUTE ORAL INTRAVENOUS USUBJID = DR001-006 | EXSEQ EXENDTC 2024-03-12 2024-02-28 USUBJID = DR001-003 | EXSEQ EPOCH TREATMENT FOLLOW-UP SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 6 Obs in COMPARE 6 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 12 Variables in COMPARE 12 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 10 Variables with all values equal 6 Variables with any differences 4 Total value differences 4 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== Report written to: sdtm_ex_comparison.txt ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : ex_planned 6 obs x 12 vars COMPARE : ex_actual 6 obs x 12 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 6 Obs in COMPARE 6 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 12 Variables in COMPARE 12 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 10 Variables with all values equal 6 Variables with any differences 4 Total value differences 4 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== [EX QC] 4 protocol deviation(s) detected in exposure data --- SCENARIO 7: SDTM MH — Medical History: eCRF vs MedDRA Coded --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : mh_ecrf 6 obs x 9 vars COMPARE : mh_coded 6 obs x 9 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (0): [suppressed] Variables WITH differences (2): MHDECOD, MHBODSYS Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = DR001-001 | MHSEQ MHDECOD High blood pressur HYPERTENSION USUBJID = DR001-002 | MHSEQ MHDECOD Type 2 diabetes TYPE 2 DIABETES ME USUBJID = DR001-004 | MHSEQ MHDECOD Heart attack MYOCARDIAL INFARCT USUBJID = DR001-006 | MHSEQ MHDECOD Depression MAJOR DEPRESSIVE D USUBJID = DR001-001 | MHSEQ MHBODSYS Cardiac Vascular disorders USUBJID = DR001-004 | MHSEQ MHBODSYS Cardiac Cardiac disorders USUBJID = DR001-006 | MHSEQ MHBODSYS Psychiatric Psychiatric disord SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 6 Obs in COMPARE 6 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 9 Variables in COMPARE 9 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 2 Variables with all values equal 0 Variables with any differences 2 Total value differences 7 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== --- SCENARIO 8: SDTM DS — Disposition: Interim vs Final Cut --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : ds_interim 7 obs x 8 vars COMPARE : ds_final 7 obs x 8 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (3): [suppressed] Variables WITH differences (3): DSTERM, DSDECOD, DSSTDTC Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = DR001-002 | DSSEQ DSTERM ADVERSE EVENT DEATH USUBJID = DR001-006 | DSSEQ DSTERM LOST TO FOLLOW-UP COMPLETED STUDY USUBJID = DR001-002 | DSSEQ DSDECOD ADVERSE EVENT DEATH USUBJID = DR001-006 | DSSEQ DSDECOD LOST TO FOLLOW-UP COMPLETED USUBJID = DR001-002 | DSSEQ DSSTDTC 2024-02-14 2024-04-02 USUBJID = DR001-006 | DSSEQ DSSTDTC 2024-04-10 2024-06-01 SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 7 Obs in COMPARE 7 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 8 Variables in COMPARE 8 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 6 Variables with all values equal 3 Variables with any differences 3 Total value differences 6 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : ds_interim 7 obs x 8 vars COMPARE : ds_final 7 obs x 8 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 7 Obs in COMPARE 7 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 8 Variables in COMPARE 8 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 6 Variables with all values equal 3 Variables with any differences 3 Total value differences 6 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== *** DEATH disposition flag changed — regulatory safety review required *** --- SCENARIO 9: SDTM SV — Subject Visits: Scheduled vs Actual Dates --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : sv_scheduled 10 obs x 7 vars COMPARE : sv_actual 10 obs x 7 vars Criterion : 0 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (3): [suppressed] Variables WITH differences (2): SVSTDTC, VISITDY Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = DR001-001 | VISITN SVSTDTC 2024-02-05 2024-02-12 USUBJID = DR001-002 | VISITN SVSTDTC 2024-02-07 2024-02-14 USUBJID = DR001-002 | VISITN SVSTDTC 2024-04-03 2024-04-15 USUBJID = DR001-001 | VISITN VISITDY 28 35 7 USUBJID = DR001-002 | VISITN VISITDY 28 35 7 USUBJID = DR001-002 | VISITN VISITDY 84 96 12 SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 10 Obs in COMPARE 10 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 7 Variables in COMPARE 7 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 5 Variables with all values equal 3 Variables with any differences 2 Total value differences 6 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== --- SCENARIO 9: SDTM TU — Tumour ID: Investigator vs Central Read --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : tu_investigator 8 obs x 8 vars COMPARE : tu_central 8 obs x 8 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (2): [suppressed] Variables WITH differences (4): TULOC, TUORRES, TUSTRESC, TUMETHOD Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = DR001-001 | TUSEQ TULOC LYMPH NODE MEDIASTINAL LYMPH USUBJID = DR001-001 | TUSEQ TUORRES TARGET NON-TARGET USUBJID = DR001-002 | TUSEQ TUORRES TARGET NON-TARGET USUBJID = DR001-001 | TUSEQ TUSTRESC TARGET NON-TARGET USUBJID = DR001-002 | TUSEQ TUSTRESC TARGET NON-TARGET USUBJID = DR001-002 | TUSEQ TUMETHOD MRI CT SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 8 Variables in COMPARE 8 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 6 Variables with all values equal 2 Variables with any differences 4 Total value differences 6 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : tu_investigator 8 obs x 8 vars COMPARE : tu_central 8 obs x 8 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 8 Variables in COMPARE 8 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 6 Variables with all values equal 2 Variables with any differences 4 Total value differences 6 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== [TU QC] 6 tumour classification differences — impacts RECIST 1.1 response --- SCENARIO 11: SDTM TR — Tumour Results: Measurement QC (1mm tolerance) --- -- With 1mm absolute tolerance for measurement precision -- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : tr_inv 8 obs x 9 vars COMPARE : tr_central 8 obs x 9 vars Criterion : 1 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (5): [suppressed] Variables WITH differences (2): TRORRES, TRSTRESN Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = DR001-001 | TRSEQ TRORRES 22 19 USUBJID = DR001-002 | TRSEQ TRORRES 28 31 USUBJID = DR001-001 | TRSEQ TRSTRESN 22 19 3 USUBJID = DR001-002 | TRSEQ TRSTRESN 28 31 3 SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 9 Variables in COMPARE 9 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 7 Variables with all values equal 5 Variables with any differences 2 Total value differences 4 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== --- SCENARIO 12: SDTM RS — Response: Investigator vs BICR Assessment --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : rs_investigator 8 obs x 9 vars COMPARE : rs_bicr 8 obs x 9 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (5): [suppressed] Variables WITH differences (2): RSORRES, RSSTRESC Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = DR001-001 | RSSEQ RSORRES PR SD USUBJID = DR001-002 | RSSEQ RSORRES SD PD USUBJID = DR001-004 | RSSEQ RSORRES SD PD USUBJID = DR001-004 | RSSEQ RSORRES SD PD USUBJID = DR001-001 | RSSEQ RSSTRESC PR SD USUBJID = DR001-002 | RSSEQ RSSTRESC SD PD USUBJID = DR001-004 | RSSEQ RSSTRESC SD PD SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 9 Variables in COMPARE 9 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 7 Variables with all values equal 5 Variables with any differences 2 Total value differences 7 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : rs_investigator 8 obs x 9 vars COMPARE : rs_bicr 8 obs x 9 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 9 Variables in COMPARE 9 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 7 Variables with all values equal 5 Variables with any differences 2 Total value differences 7 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== [RS QC] 5 response upgraded to PD by BICR — recalculate PFS! --- SCENARIO 13: SDTM EG — ECG: Central Lab vs Site ECG Values --- -- With 5ms tolerance for ECG measurement precision -- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : eg_site 10 obs x 9 vars COMPARE : eg_central 10 obs x 9 vars Criterion : 5 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (5): [suppressed] Variables WITH differences (2): EGSTRESN, EGNRIND Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = DR001-001 | EGSEQ EGSTRESN 162 168 6 USUBJID = DR001-002 | EGSEQ EGSTRESN 430 448 18 USUBJID = DR001-002 | EGSEQ EGNRIND NORMAL HIGH SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 10 Obs in COMPARE 10 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 9 Variables in COMPARE 9 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 7 Variables with all values equal 5 Variables with any differences 2 Total value differences 3 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : eg_site 10 obs x 9 vars COMPARE : eg_central 10 obs x 9 vars Criterion : 5 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 10 Obs in COMPARE 10 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 9 Variables in COMPARE 9 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 7 Variables with all values equal 5 Variables with any differences 2 Total value differences 3 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== *** QTcF > 450ms flagged by central lab — safety review required! *** --- SCENARIO 14: SDTM PE — Physical Exam: Site vs Medical Monitor Review --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : pe_site 12 obs x 8 vars COMPARE : pe_monitor 12 obs x 8 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (4): [suppressed] Variables WITH differences (2): PEORRES, PENORIND Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = DR001-001 | PESEQ PEORRES NORMAL ABNORMAL USUBJID = DR001-002 | PESEQ PEORRES ABNORMAL NORMAL USUBJID = DR001-003 | PESEQ PEORRES NORMAL ABNORMAL USUBJID = DR001-001 | PESEQ PENORIND NORMAL ABNORMAL USUBJID = DR001-002 | PESEQ PENORIND ABNORMAL NORMAL USUBJID = DR001-003 | PESEQ PENORIND NORMAL ABNORMAL SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 12 Obs in COMPARE 12 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 8 Variables in COMPARE 8 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 6 Variables with all values equal 4 Variables with any differences 2 Total value differences 6 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== --- SCENARIO 15: SDTM QS — Questionnaire: Paper CRF vs eDiary --- -- Zero tolerance: every integer difference is a transcription error -- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : qs_paper 15 obs x 9 vars COMPARE : qs_ediary 15 obs x 9 vars Criterion : 0 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (5): [suppressed] Variables WITH differences (2): QSORRES, QSSTRESN Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = DR001-001 | QSSEQ QSORRES 2 3 USUBJID = DR001-002 | QSSEQ QSORRES 2 3 USUBJID = DR001-003 | QSSEQ QSORRES 1 2 USUBJID = DR001-001 | QSSEQ QSSTRESN 2 3 1 USUBJID = DR001-002 | QSSEQ QSSTRESN 2 3 1 USUBJID = DR001-003 | QSSEQ QSSTRESN 1 2 1 SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 15 Obs in COMPARE 15 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 9 Variables in COMPARE 9 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 7 Variables with all values equal 5 Variables with any differences 2 Total value differences 6 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : qs_paper 15 obs x 9 vars COMPARE : qs_ediary 15 obs x 9 vars Criterion : 0 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 15 Obs in COMPARE 15 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 9 Variables in COMPARE 9 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 7 Variables with all values equal 5 Variables with any differences 2 Total value differences 6 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== [QS QC] 6 PRO transcription errors detected — source data verification required --- SCENARIO 16: SDTM DM — Demographics: Race/Ethnicity Coding QC --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : dm_ecrf 8 obs x 9 vars COMPARE : dm_coded 8 obs x 9 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (6): [suppressed] Variables WITH differences (2): RACE, AGE Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = DR001-006 RACE OTHER NATIVE HAWAIIAN OR USUBJID = DR001-007 AGE 33 34 1 SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 9 Variables in COMPARE 9 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 8 Variables with all values equal 6 Variables with any differences 2 Total value differences 2 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== --- SCENARIO 17: SDTM LB — Urinalysis & Coagulation: Reference Range QC --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : lb_panel 12 obs x 11 vars COMPARE : lb_panel_qc 12 obs x 11 vars Criterion : 0.01 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (6): [suppressed] Variables WITH differences (3): LBSTRESN, LBSTNRHI, LBNRIND Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = DR001-002 | LBSEQ LBSTRESN 13.2 13.1 0.1 USUBJID = DR001-002 | LBSEQ LBSTRESN 1 0 1 USUBJID = DR001-001 | LBSEQ LBSTNRHI 35 36 1 USUBJID = DR001-002 | LBSEQ LBSTNRHI 35 36 1 USUBJID = DR001-002 | LBSEQ LBNRIND HIGH NORMAL USUBJID = DR001-002 | LBSEQ LBNRIND HIGH NORMAL SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 12 Obs in COMPARE 12 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 11 Variables in COMPARE 11 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 9 Variables with all values equal 6 Variables with any differences 3 Total value differences 6 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== --- SCENARIO 18: SDTM AE — SAE Flags: Safety Database vs SDTM --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : ae_safety_db 6 obs x 12 vars COMPARE : ae_sdtm 6 obs x 12 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (2): [suppressed] Variables WITH differences (3): AESDTH, AESDISAB, AESMIE Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = DR001-006 | AESEQ AESDTH N Y USUBJID = DR001-003 | AESEQ AESDISAB N Y USUBJID = DR001-002 | AESEQ AESMIE N Y SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 6 Obs in COMPARE 6 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 12 Variables in COMPARE 12 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 5 Variables with all values equal 2 Variables with any differences 3 Total value differences 3 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : ae_safety_db 6 obs x 12 vars COMPARE : ae_sdtm 6 obs x 12 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 6 Obs in COMPARE 6 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 12 Variables in COMPARE 12 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 5 Variables with all values equal 2 Variables with any differences 3 Total value differences 3 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== *** AESDTH=Y added — expedited 7/15-day safety report required *** --- SCENARIO 19: SDTM SU — Substance Use: eCRF vs IRT System --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : su_ecrf 10 obs x 9 vars COMPARE : su_irt 10 obs x 9 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (5): [suppressed] Variables WITH differences (2): SUOCCUR, SUDOSE Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = DR001-002 | SUSEQ SUOCCUR N Y USUBJID = DR001-004 | SUSEQ SUOCCUR N Y USUBJID = DR001-002 | SUSEQ SUDOSE 0 5 5 USUBJID = DR001-004 | SUSEQ SUDOSE 0 8 8 USUBJID = DR001-005 | SUSEQ SUDOSE 20 25 5 SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 10 Obs in COMPARE 10 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 9 Variables in COMPARE 9 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 7 Variables with all values equal 5 Variables with any differences 2 Total value differences 5 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== --- SCENARIO 20: SDTM RELREC — Related Records: AE-CM Linkage QC --- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : relrec_base 8 obs x 7 vars COMPARE : relrec_compare 8 obs x 7 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:09 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 3 - Value Comparison ------------------------------------------------------------------------ Variables with no differences (0): [suppressed] Variables WITH differences (4): STUDYID, IDVAR, RELTYPE, RELID Obs ID Variable BASE value COMPARE value Difference ---------------------------- ------------------ ------------------ ------------------ ------------ USUBJID = DR001-003 | RDOMAI STUDYID DR001 NA USUBJID = DR001-003 | RDOMAI STUDYID NA DR001 USUBJID = DR001-003 | RDOMAI IDVAR SEQ NA USUBJID = DR001-003 | RDOMAI IDVAR NA SEQ USUBJID = DR001-003 | RDOMAI RELTYPE MANY NA USUBJID = DR001-003 | RDOMAI RELTYPE NA MANY USUBJID = DR001-004 | RDOMAI RELTYPE MANY ONE USUBJID = DR001-003 | RDOMAI RELID AE03 NA USUBJID = DR001-003 | RDOMAI RELID NA AE03 USUBJID = DR001-003 | RDOMAI RELID AE03 AE03B SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 1 Obs in COMPARE only 1 Variables in BASE 7 Variables in COMPARE 7 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 4 Variables with all values equal 0 Variables with any differences 4 Total value differences 10 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== ======================================================================== SDTM SCENARIOS — SUMMARY ======================================================================== No. Domain Use Case Result ---- ------------ -------------------------------- ---------------------- ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 6 obs x 12 vars COMPARE : s[[5]] 6 obs x 12 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 6 Obs in COMPARE 6 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 12 Variables in COMPARE 12 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 11 Variables with all values equal 8 Variables with any differences 3 Total value differences 3 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 01 SDTM DM Data Cut 1 vs Data Cut 2 HAS DIFFERENCES (3 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 7 obs x 11 vars COMPARE : s[[5]] 7 obs x 11 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 7 Obs in COMPARE 7 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 11 Variables in COMPARE 11 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 9 Variables with all values equal 6 Variables with any differences 3 Total value differences 3 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 02 SDTM AE Sponsor vs CRO Reconciliation HAS DIFFERENCES (3 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 8 obs x 13 vars COMPARE : s[[5]] 8 obs x 13 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 13 Variables in COMPARE 13 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 11 Variables with all values equal 8 Variables with any differences 3 Total value differences 4 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 03 SDTM LB Central Lab Extract vs SDTM Mapped HAS DIFFERENCES (4 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 6 obs x 11 vars COMPARE : s[[5]] 6 obs x 11 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 6 Obs in COMPARE 6 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 11 Variables in COMPARE 11 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 9 Variables with all values equal 6 Variables with any differences 3 Total value differences 3 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 04 SDTM CM eCRF vs WHODrug Coded Dataset HAS DIFFERENCES (3 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 8 obs x 11 vars COMPARE : s[[5]] 8 obs x 11 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 11 Variables in COMPARE 11 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 9 Variables with all values equal 7 Variables with any differences 2 Total value differences 10 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 05 SDTM CM Baseline vs Week 24 Derivation QC HAS DIFFERENCES (10 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 6 obs x 12 vars COMPARE : s[[5]] 6 obs x 12 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 6 Obs in COMPARE 6 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 12 Variables in COMPARE 12 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 10 Variables with all values equal 6 Variables with any differences 4 Total value differences 4 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 06 SDTM EX Planned vs actual dose HAS DIFFERENCES (4 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 6 obs x 9 vars COMPARE : s[[5]] 6 obs x 9 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 6 Obs in COMPARE 6 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 9 Variables in COMPARE 9 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 7 Variables with all values equal 5 Variables with any differences 2 Total value differences 7 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 07 SDTM MH eCRF vs MedDRA coded HAS DIFFERENCES (7 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 7 obs x 8 vars COMPARE : s[[5]] 7 obs x 8 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 7 Obs in COMPARE 7 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 8 Variables in COMPARE 8 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 6 Variables with all values equal 3 Variables with any differences 3 Total value differences 6 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 09 SDTM DS Interim vs final cut HAS DIFFERENCES (6 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 10 obs x 7 vars COMPARE : s[[5]] 10 obs x 7 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 10 Obs in COMPARE 10 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 7 Variables in COMPARE 7 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 5 Variables with all values equal 3 Variables with any differences 2 Total value differences 6 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 10 SDTM SV Scheduled vs actual visits HAS DIFFERENCES (6 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 8 obs x 8 vars COMPARE : s[[5]] 8 obs x 8 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 8 Variables in COMPARE 8 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 6 Variables with all values equal 2 Variables with any differences 4 Total value differences 6 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 11 SDTM TU Investigator vs central read HAS DIFFERENCES (6 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 8 obs x 9 vars COMPARE : s[[5]] 8 obs x 9 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 9 Variables in COMPARE 9 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 7 Variables with all values equal 5 Variables with any differences 2 Total value differences 6 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 12 SDTM TR Tumour measurement QC (1mm) HAS DIFFERENCES (6 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 8 obs x 9 vars COMPARE : s[[5]] 8 obs x 9 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 9 Variables in COMPARE 9 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 7 Variables with all values equal 5 Variables with any differences 2 Total value differences 7 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 13 SDTM RS Investigator vs BICR HAS DIFFERENCES (7 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 10 obs x 9 vars COMPARE : s[[5]] 10 obs x 9 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 10 Obs in COMPARE 10 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 9 Variables in COMPARE 9 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 7 Variables with all values equal 5 Variables with any differences 2 Total value differences 5 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 14 SDTM EG Site vs central ECG (5ms) HAS DIFFERENCES (5 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 12 obs x 8 vars COMPARE : s[[5]] 12 obs x 8 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 12 Obs in COMPARE 12 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 8 Variables in COMPARE 8 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 6 Variables with all values equal 4 Variables with any differences 2 Total value differences 6 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 15 SDTM PE Site vs medical monitor HAS DIFFERENCES (6 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 15 obs x 9 vars COMPARE : s[[5]] 15 obs x 9 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 15 Obs in COMPARE 15 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 9 Variables in COMPARE 9 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 7 Variables with all values equal 5 Variables with any differences 2 Total value differences 6 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 16 SDTM QS Paper CRF vs eDiary HAS DIFFERENCES (6 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 8 obs x 9 vars COMPARE : s[[5]] 8 obs x 9 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 9 Variables in COMPARE 9 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 8 Variables with all values equal 6 Variables with any differences 2 Total value differences 2 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 17 SDTM DM Race/ethnicity coding QC HAS DIFFERENCES (2 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 12 obs x 11 vars COMPARE : s[[5]] 12 obs x 11 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 12 Obs in COMPARE 12 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 11 Variables in COMPARE 11 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 9 Variables with all values equal 6 Variables with any differences 3 Total value differences 6 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 18 SDTM LB Urinalysis & coagulation HAS DIFFERENCES (6 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 6 obs x 12 vars COMPARE : s[[5]] 6 obs x 12 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 6 Obs in COMPARE 6 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 12 Variables in COMPARE 12 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 10 Variables with all values equal 7 Variables with any differences 3 Total value differences 3 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 19 SDTM AE SAE flags reconciliation HAS DIFFERENCES (3 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 10 obs x 9 vars COMPARE : s[[5]] 10 obs x 9 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 10 Obs in COMPARE 10 Obs in BASE only 0 Obs in COMPARE only 0 Variables in BASE 9 Variables in COMPARE 9 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 7 Variables with all values equal 5 Variables with any differences 2 Total value differences 5 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 20 SDTM SU eCRF vs IRT system HAS DIFFERENCES (5 diff) ======================================================================== rDataRecon - Dataset Comparison Report ======================================================================== BASE : s[[4]] 8 obs x 7 vars COMPARE : s[[5]] 8 obs x 7 vars Criterion : 1e-08 (absolute) Run time : 2026-03-31 10:17:10 ------------------------------------------------------------------------ SECTION 1 - Variable Structure ------------------------------------------------------------------------ In BASE only ( 0) : none In COMPARE only ( 0) : none SECTION 2 - Variable Type Mismatches ------------------------------------------------------------------------ All common variables have matching types. SECTION 4 - Summary Statistics ------------------------------------------------------------------------ Obs in BASE 8 Obs in COMPARE 8 Obs in BASE only 1 Obs in COMPARE only 1 Variables in BASE 7 Variables in COMPARE 7 Variables in BASE only 0 Variables in COMPARE only 0 Variables with type mismatches 0 Variables compared 4 Variables with all values equal 0 Variables with any differences 4 Total value differences 10 ======================================================================== VERDICT : DATASETS HAVE DIFFERENCES ======================================================================== 21 SDTM RELREC AE-CM linkage QC HAS DIFFERENCES (10 diff) ======================================================================== [ FAIL 0 | WARN 0 | SKIP 2 | PASS 46 ] ══ Skipped tests (2) ═══════════════════════════════════════════════════════════ • empty test (2): , [ FAIL 0 | WARN 0 | SKIP 2 | PASS 46 ] > > proc.time() user system elapsed 2.09 0.39 2.50